Observational influenza vaccine active surveillance study: A Phase IV Prospective Multi-Centre Cohort Study to Evaluate the Reactogenicity of bioCSL’s influenza virus vaccine (CSLCT-SAF-14-05)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/14343
• EU PAS number:
  EUPAS7301
• Study ID:
  14343
• Official title and acronym:
  Observational influenza vaccine active surveillance study: A Phase IV Prospective Multi-Centre Cohort Study to Evaluate the Reactogenicity of bioCSL’s influenza virus vaccine (CSLCT-SAF-14-05)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  To characterise the reactogenicity (local, systemic and allergic reactions) within seven days after each influenza vaccination with bioCSL’s influenza virus vaccine in participants routinely indicated for influenza vaccination in specified age groups.To assess the frequency and severity of medically attended adverse events with initial symptom onset within seven days after each influenza vaccination with bioCSL’s influenza virus vaccine.
• Study status:
  Finalised

Research institutions and networks

Institutions

Harbinson House Surgery

Harbinson House Surgery

Knowle House Surgery PL5 3JB Plymouth, UK, The Rame Group Practice PL11 2JW Torpoint, UK, The Honiton Surgery Ward Practice EX14 2NY Honiton, Leicester Terrace Healthcare Centre NN2 6AL Northampton, Bradford on Avon Health Centre BA15 1DQ Bradford-on-Avon, Axbridge and Wedmore Medical Practice BS26 2BJ Axbridge, Harbinson House Surgery TS21 3BN Sedgefield, The Haven Surgery DH7 OBD Burnhope, University of Nottingham Health Service NG7 2QW Nottingham, East Quay Medical Centre TA6 4GP Bridgwater

Networks

NIHR Medicines for Children Research Network

Study timelines

Date when funding contract was signed

Planned: 18/07/2014

Actual: 18/07/2014

Study start date

Planned: 01/10/2014

Actual: 03/10/2014

Data analysis start date

Planned: 09/10/2014

Actual: 24/10/2014

Date of interim report, if expected

Planned: 30/10/2014

Actual: 03/11/2014

Date of final study report

Planned: 05/02/2016

Actual: 11/02/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

bioCSL GmbH

Study protocol

Initial protocol

CSLCT-SAF-14-05_PASS Abstract_V1_4-AUG-14

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 2 (specific obligation of marketing authorisation)